Supplements Sold Nationwide Recalled Over Potentially Severe "Adverse Events"
If you have a mineral or vitamin deficiency—whether you're lacking in iron, zinc, or magnesium—adding a supplement can be an easy fix. Simply add a pill to your morning routine, and you can fuel your body with the extra oomph it needs. But if your doctor recommends you take supplements for low potassium, you might want to heed a new warning from the U.S. Food and Drug Administration (FDA). Per a June 24 recall notice, 114 batches of potassium chloride supplements have been recalled.
RELATED: Coffee Sold Nationwide Is Being Recalled Over Potential "Deadly Toxin," FDA Says.
The recall was initiated by Glenmark Pharmaceuticals Inc., USA, which voluntarily pulled 114 batches of its Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEqK. According to the FDA notice, the products were distributed nationwide to the consumer level and retail outlets, as well as to wholesalers and distributors.
The potassium chloride supplements are being recalled due to "failed dissolution," which can lead to high potassium levels. According to the United States Pharmacopeia (USP), different supplements and medications undergo dissolution testing, which measures the "extent and rate of solution formation from a dosage form." Dissolution is also known as drug release, which is important for the treatment's effectiveness.
Having high potassium levels is formally known as hyperkalemia, and it can cause serious conditions, such as an irregular heartbeat and potentially cardiac arrest, the FDA warns.
"For patients who require chronic use of potassium chloride extended-release oral capsules, especially in those patients with underlying comorbidities or conditions that cause altered excretory mechanisms for potassium such as hypertension, heart failure, or renal dysfunction, there is a reasonable probability of developing hyperkalemia that may lead to a range of severity of adverse events from being asymptomatic to more severe potential life threatening adverse events of hyperkalemia such as cardiac arrythmias, severe muscle weakness, and death," the FDA notice reads.
RELATED: Sunscreen Sold Nationwide Is Being Recalled Over Mold.
Recalled potassium supplements were sold in bottles of 100-count and 500-count capsules and have expiration dates between June 2024 and Sept. 2025. A separate FDA document details all 114 of the specific product names, national drug codes (NDCs), batch numbers, and expiration dates included in the recall. You can identify recalled products using this information and the brand name "Glenmark," which is printed on the packaging.
If you have any recalled supplements at home, the FDA asks that you consult your physician or healthcare provider before you stop using them. The agency also advises you to consult a healthcare professional if you experience any issues related to the recalled potassium supplements. Any side effects or complications should be reported to the FDA's MedWatch Adverse Event Reporting program online or via regular mail or fax.
Glenmark Pharmaceuticals Inc. is actively notifying wholesalers and distributors of the recall via written letters and arranging for the return of recalled products. The FDA asks that anyone with the supplements "discontinue distribution of the recalled product lots immediately and follow the instructions provided in the written recall letter." Both wholesalers and distributors are also instructed to conduct a sub-recall to their retail and pharmacy customers.
If you have specific questions about the recall, you can reach Glenmark directly at the email address or phone number listed in the FDA notice.
Abby Reinhard Abby Reinhard is a Senior Editor at Best Life, covering daily news and keeping readers up to date on the latest style advice, travel destinations, and Hollywood happenings.Read moreFiled UnderMedicine • News • RecallSources referenced in this article- Source: U.S. FDA: Glenmark Pharmaceuticals Inc., USA Issues Voluntary Nationwide Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution
- Source: U.S. FDA: Recalled Potassium Chloride Supplements Informational Table
Ice Cream Sold Nationwide Is Being Recalled
Impacted brands include Jeni's, Friendly's, and Hershey's, among several others.June 25, 2024Dog Treats Sold Nationwide Are Being Recalled
TDBBS LLC is pulling 3,551 bags of green tripe-flavored treats.June 24, 2024Coffee Sold Nationwide Is Being Recalled
A number of different canned coffee products are impacted by the latest recall.June 21, 2024Sunscreen Sold Nationwide Is Being Recalled
The FDA just shared a new notice about Suntegrity Skincare sunscreen.June 13, 2024Cookie Dough Sold at Costco Is Being Recalled
Nearly 30,000 cases of cookie dough products are being recalled.June 12, 2024Mouthwash Is Being Recalled, FDA Says
Two StellaLife-brand oral care products are impacted by the recall.June 10, 2024Costco Is Recalling Cheese Slices
The retailer just issued a new alert regarding Tillamook cheese slices.June 7, 2024Fiji Water Bottles Are Being Recalled
Almost 79,000 cases of water were affected by the recall.May 31, 2024Dog Food Recalled Over "Loose Metal Pieces"
Nearly 14,000 pounds of dog food are being pulled from shelves.May 20, 2024Stoves Sold at Sears Are Being Recalled
The CPSC reissued the recall due to additional reports of "ranges behaving erratically."May 17, 2024
